A Study of AMDX-2011P in Participants With Alzheimer's Disease

Last updated: July 24, 2024
Sponsor: Amydis Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

AMDX-2011P

Clinical Study ID

NCT06514001
AMDX-2011P-204
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimer's Disease (AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloidbeta signal via positron emission tomography (PET) brain scan

  2. Must be willing to consent to genotyping for apolipoprotein E (APOE)

  3. Ability to fixate and undergo retinal imaging of both eyes

Exclusion

Exclusion Criteria:

  1. Presence of any underlying physical or psychological medical condition that, in theopinion of the investigator, would make it unlikely that the participant willcomplete the study per protocol

  2. Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined byan ophthalmologist as a clinical investigator, based on results from the eyeexamination, visual field, and/or optical coherence tomography (OCT) results

  3. Diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms ofage-related macular degeneration (AMD) in either eye, OR as determined by anophthalmologist as a clinical investigator, based on results from the eyeexamination and/or optical coherence tomography (OCT) results

  4. Clinically significant laboratory abnormalities as assessed by the investigator

  5. Prolonged QTcF (corrected QT interval by Fridericia method) (>450 ms for males and >470 ms for females), cardiac arrhythmia, or any clinically significant abnormalityin the resting electrocardiogram (ECG), as judged by the investigator.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: AMDX-2011P
Phase: 2
Study Start date:
July 01, 2024
Estimated Completion Date:
March 31, 2025

Study Description

This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with AD. Assessments of retinal images will be conducted by central masked assessors.

Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.

Connect with a study center

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Global Research Management

    Glendale, California 91204
    United States

    Active - Recruiting

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Active - Recruiting

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